Hypotension Drug-InducedPhase 4NCT06334549
A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia
A Phase 4 study testing Ephedrine-P, Phenylephrine-P and Norepinephrine-P in people with Hypotension Drug-Induced, run by Dalian Municipal Central Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Ephedrine-P, Phenylephrine-P and Norepinephrine-P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2024to 5 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III, age 18-80 years
- Elective abdominal surgery
- Signed informed consent
Who cannot join
- ASA≥IV
- Preoperative unstable blood hemodynamics
- Allergy to ephedrine, phenylephrine or norepinephrine
- Decrease in MAP <20%
- Severe cardiovascular disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning, 116033
Liping Han, M.D.
About this study
Official title: Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.
Read the detailed description
This study was a single-center, randomized, double-blinded, controlled trial. First, the effects of E, P, or N on cerebral oxygen saturation(rScO2) under general anesthesia in abdominal surgery were studied. Patients with abdominal surgery were evaluated using near-infrared spectroscopy. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured with LiDCO rapidV3 monitoring system. To investigate the individualized therapeutic options \& specific mechanisms of the three vasopressors on rScO2 and CO.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Ephedrine-P, Phenylephrine-P, Norepinephrine-P, Ephedrine-S, Phenylephrine-S
- Keywords
- Abdominal surgery, ephedrine, phenylephrine, norepinephrine, cerebral oxygen saturation, MAP, CO, General anesthesia, Propofol, Sevoflurane, Hypotension Drug-induced
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ephedrine-PDrug
Also called vasopressor
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Phenylephrine-PDrug
Also called vasopressor
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Norepinephrine-PDrug
Also called vasopressor
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Ephedrine-SDrug
Also called vasopressor
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Phenylephrine-SDrug
Also called vasopressor
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Norepinephrine-SDrug
Also called vasopressor
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine-Propofol | Experimental | receive ephedrine 0.15mg/kg (configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Ephedrine-P |
| Phenylephrine-propofol | Experimental | receive phenylephrine 2.5ug/kg(configured concentration 100ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Phenylephrine-P |
| Norepinephrine-propofol | Experimental | receive norepinephrine 0.2ug/kg(configured concentration 8μg/ml) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Norepinephrine-P |
| Ephedrine-sevoflurane | Active comparator | receive Ephedrine 0.15mg/kg(configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Ephedrine-S |
| Phenylephrine-sevoflurane | Active comparator | receive phenylephrine 2.5ug/kg(configured concentration 80ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Phenylephrine-S |
| Norepinephrine-sevoflurane | Active comparator | receive norepinephrine 0.2ug/kg(configured concentration 8ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. Receives: Drug: Norepinephrine-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continual changes in Cerebral Oxygen Saturation
This outcome is measured by near-infrared spectroscopy
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Secondary outcomes (5)
Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)
This outcome is measured by LiDCO rapidV3 monitoring system
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in heart rate (HR)
This outcome is measured by LiDCO rapidV3 monitoring system
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in stroke volume (SV)
This outcome is measured by LiDCO rapidV3 monitoring system
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in cardiac output (CO)
This outcome is measured by LiDCO rapidV3 monitoring system
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in systemic vascular resistance (SVR)
This outcome is measured by LiDCO rapidV3 monitoring system
Measured: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start5 Mar 2024
- Primary completion5 Dec 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Municipal Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Han, Dalian Municipal Central Hospital
- Investigators
- Hong Fang, MD, Study chair, Dalian Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334549
- Sponsor's protocol ID
- LSKY2023-107-01
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06334549
- Acronym / sponsor ID
- LSKY2023-107-01
- Conditions
- Hypotension Drug-Induced
- Keywords
- Abdominal surgery, ephedrine, phenylephrine, norepinephrine, cerebral oxygen saturation, MAP, CO, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dalian Municipal Central HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.
Detailed description
This study was a single-center, randomized, double-blinded, controlled trial. First, the effects of E, P, or N on cerebral oxygen saturation(rScO2) under general anesthesia in abdominal surgery were studied. Patients with abdominal surgery were evaluated using near-infrared spectroscopy. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured with LiDCO rapidV3 monitoring system. To investigate the individualized therapeutic options \& specific mechanisms of the three vasopressors on rScO2 and CO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ephedrine-Propofol | Experimental | Drug: Ephedrine-Preceive ephedrine 0.15mg/kg (configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
| Phenylephrine-propofol | Experimental | Drug: Phenylephrine-Preceive phenylephrine 2.5ug/kg(configured concentration 100ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
| Norepinephrine-propofol | Experimental | Drug: Norepinephrine-Preceive norepinephrine 0.2ug/kg(configured concentration 8μg/ml) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
| Ephedrine-sevoflurane | Active comparator | Drug: Ephedrine-Sreceive Ephedrine 0.15mg/kg(configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
| Phenylephrine-sevoflurane | Active comparator | Drug: Phenylephrine-Sreceive phenylephrine 2.5ug/kg(configured concentration 80ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
| Norepinephrine-sevoflurane | Active comparator | Drug: Norepinephrine-Sreceive norepinephrine 0.2ug/kg(configured concentration 8ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III, age 18-80 years
- Elective abdominal surgery
- Signed informed consent
Key exclusion criteria (5 listed)
- ASA≥IV
- Preoperative unstable blood hemodynamics
- Allergy to ephedrine, phenylephrine or norepinephrine
- Decrease in MAP <20%
- Severe cardiovascular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ephedrine-PAlso: vasopressorafter induction of anesthesia, use total intravenous anesthesia maintained with propofol | Drug | Ephedrine-Propofol |
| Phenylephrine-PAlso: vasopressorafter induction of anesthesia, use total intravenous anesthesia maintained with propofol | Drug | Phenylephrine-propofol |
| Norepinephrine-PAlso: vasopressorafter induction of anesthesia, use total intravenous anesthesia maintained with propofol | Drug | Norepinephrine-propofol |
| Ephedrine-SAlso: vasopressorafter induction of anesthesia, use inhalation anesthesia maintained with sevoflurane | Drug | Ephedrine-sevoflurane |
| Phenylephrine-SAlso: vasopressorafter induction of anesthesia, use inhalation anesthesia maintained with sevoflurane | Drug | Phenylephrine-sevoflurane |
| Norepinephrine-SAlso: vasopressorafter induction of anesthesia, use inhalation anesthesia maintained with sevoflurane | Drug | Norepinephrine-sevoflurane |
Primary outcome
Continual changes in Cerebral Oxygen Saturation
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by near-infrared spectroscopy
5 secondary outcomes
Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in heart rate (HR)
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in stroke volume (SV)
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in cardiac output (CO)
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in systemic vascular resistance (SVR)
Time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Fang, MD study chair
Dalian Municipal Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ephedrine-P, Phenylephrine-P and Norepinephrine-P in people with Hypotension Drug-Induced, run by Dalian Municipal Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liping Han, MD, MSc (86-411-84412001, han651310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continual changes in Cerebral Oxygen Saturation (time frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.